The Recall Desk
ModerateFDA (Drugs)·D-0680-2022·Announced 2022-03-30

Diclofenac Sodium Topical Solution Recalled for Manufacturing Compliance Deviations

Teligent Pharma recalled 36,018 bottles of Diclofenac Sodium Topical Solution nationwide due to cGMP deviations related to discontinued stability studies, affecting all batches through May 2024.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II precautionary recall with no reported illnesses or injuries. The recall stems from manufacturing process deviations (discontinued stability studies) that prevent verification of product quality through expiration.

Plain-English summary

Teligent Pharma, Inc. is recalling all Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. bottles distributed nationwide in the USA and Puerto Rico. The recall affects 36,018 bottles across multiple batches with expiration dates through May 31, 2024.

The recall was issued because the manufacturer discontinued its stability study program, creating a current Good Manufacturing Practice (cGMP) deviation. The firm can no longer verify that the product maintains its quality and safety profile throughout its stated shelf life.

Consumers in possession of affected Diclofenac Sodium Topical Solution should stop using the product and contact their healthcare provider or pharmacist for guidance. Patients taking this medication should not discontinue treatment without medical consultation and should speak with their provider about alternative options.

The recalled product

Product
Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70810, NDC 70512-025-05.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical
Hazard
Affected units
36,018

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Batch: 15384
  • Exp. 3/31/2023
  • 15646
  • Exp. 5/31/2023
  • 15971
  • Exp. 9/30/2023
  • 16206
  • 16226
  • Exp. 11/30/2023
  • 16268
  • Exp. 12/31/2023
  • 16342
  • 16343
  • Exp. 1/31/2024
  • 16503
  • 16504
  • Exp. 3/31/2024
  • 16632
  • Exp. 4/30/2024
  • 16715

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 37 recalled by Teligent Pharma, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 37 products in this recall →

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Same hazard · cGMP deviation

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